Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

Frailty Clinical Trial

Official title:

Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522533
• Other study ID #: IRB15-0192
• Status: Completed
• Phase: N/A
• Start date: July 20, 2015
• Est. completion date: October 16, 2017

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Frailty has been associated with poor acute and long-term outcomes after major surgery. We recently determined that nearly 70% of patients undergoing major thoracic surgery are pre-frail or frail. We are interested in assessing whether a strength training intervention for frail or pre-frail patients has an impact on surgical decision making and on surgical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 16, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria: • Age =60 years, • Qualified to consent for participation in a research study, •Thoracic disease that may require major surgery (major anatomic lung resection, esophagectomy, repair of giant paraesophageal hernia, chest wall resection, extended pleurectomy/decortication, thymectomy or major surgery for other mediastinal process),• No obvious contraindications to surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would prevent surgery), • Ability to participate in physical therapy and an independent exercise program for frailty mitigation, •No need for induction chemotherapy or radiation therapy, • Recent evaluation including computed tomography of the chest or chest/abdomen.

Exclusion Criteria:• Age <60 years, •Unable to provide informed consent, • No indication for major thoracic surgery, •Obvious contraindication to major thoracic surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would preclude surgery),• Inability to participate in physical therapy and/or an independent home exercise for frailty mitigation, •Need for induction chemotherapy or radiation therapy

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Physical Therapy
6 weeks of an exercise program.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the degree of frailty after strength training		18 months
Secondary	Changes in surgeon risk assessment after strength training		18 months